Frequently Asked Questions for Electronic Prescribing of ...

[Pages:22]FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES

EPCS

Revised: April 2015

NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement

1-866-811-7957 health.professionals/narcotic

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

Contents

Laws and Regulations for Electronic Prescribing of Controlled Substances (EPCS)..........................Page 1 Physician Assistant and Pharmacy EPCS Registration Form................................................................Page 7 Registration for Official Prescriptions and E-prescribing Systems (ROPES).......................................Page 12 Software and Data Requirements...........................................................................................................Page 18 Waivers and Exceptions............................................................................................................................Page 19 Resource Information and Contacts.......................................................................................................Page 20

Laws and Regulations for Electronic Prescribing of Controlled Substances (EPCS)

Q1: What is Electronic Prescribing of Controlled Substances or EPCS?

A1: Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on March 27, 2013. The amendments authorize a practitioner to issue an electronic prescription for controlled substances in Schedules II through V and allow a pharmacist to accept, annotate, dispense and electronically archive such prescriptions. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health Law. Click

on the following link for Section 3302; Section 3302 Article 33 Public Health Law.

Q2: Is an electronic facsimile of a prescription considered an electronic prescription?

A2: No. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health

Law and specifically states that a prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription. Click on the following link for Section 3302: Section 3302 Article 33 Public Health Law.

Q3: Is EPCS mandatory for New York State practitioners?

A3: As of March 27, 2016 it will be mandatory for practitioners, excluding veterinarians, to issue electronic prescriptions for controlled and non-controlled substances.

Q4: Why will electronic prescribing of controlled and non-controlled substances be mandatory effective March 27, 2016?

A4: New York Education Law Article 137 ?6810 requires that all prescriptions be transmitted electronically three years from the Department of Health's promulgating regulations allowing for the electronic prescribing of controlled substances. These regulations became effective on March 27, 2013. Utilizing modern prescription technology has the potential to minimize medication errors for patients in New York State. Electronic prescribing also allows for the integration of prescription records directly into the patient's electronic medical record. Electronic prescribing has the potential to reduce prescription theft and forgery.

New York State Department of Health

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Bureau of Narcotic Enforcement

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

Q5: I currently electronically prescribe non-controlled substances. Are there any additional steps I need to complete in order to electronically prescribe controlled substances?

A5: Yes.

First, the software you currently use must meet all the federal security requirements for EPCS, which can be found on the Drug Enforcement Agency's (DEA) web page. Note that federal security requirements include a third party audit or DEA certification of the software. Second, you must complete the identity proofing process as defined in the federal requirements. Third, you must obtain a two-factor authentication as defined in the federal requirements. Fourth, you must register your DEA certified EPCS software with the Bureau of Narcotic Enforcement (BNE). Registration instructions are included in the FAQs.

Q6: Can I electronically prescribe controlled substances before it becomes mandated on March 27, 2016?

A6: EPCS became permissible in NYS on March 27, 2013. Practitioners can electronically prescribe controlled substances if:

The EPCS software application meets all of the federal security requirements for EPCS, which can be found on the DEA's web page. Note that federal security requirements include a third party audit or DEA certification of the software.

The practitioner has completed identity proofing as defined in the federal requirements and The practitioner has obtained a two-factor authentication as defined in the federal

requirements and The practitioner has registered their DEA certified EPCS software application with the Bureau

of Narcotic Enforcement (BNE). Please refer to the Registration instructions included below in the section titled "Registration for Official Prescriptions and E-prescribing Systems" or "Physician Assistant and Pharmacy EPCS Registration Form", whichever is applicable.

Q7: Will the use of Official New York State Prescription forms be prohibited as of March 27, 2016?

A7: Official New York State Prescription forms may be used in the event of a power outage or technical failure, or by practitioners who meet one of the exceptions listed in Article 2A - Section 281 or Title 10 Part 80 Section 80.64. Please review this section of the law and regulations, which may be accessed from the following links: Article 2A - Section 281 and Title 10 Part 80 Section 80.64

Q8: I work for the Department of Veterans Affairs on federal property. Do I need to register my certified EPCS software application with BNE?

A8: No, practitioners who practice on federal property do not fall under the jurisdiction of New York State. However, a practitioner working on federal property who also practices off of federal property within New York State, the EPCS software application that is used off of federal property must be registered with BNE.

New York State Department of Health

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Bureau of Narcotic Enforcement

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

Q9: Will practitioners be required to issue electronic prescriptions for compounds containing a controlled substance ingredient as of March 27, 2016?

A9: BNE is aware that there may be system limitations due to the NCPDP script standard. Please monitor BNE's webpage for more information.

Q10: Will practitioners be required to electronically prescribe non-prescription items, including durable medical equipment, which require a prescription for payment by the third party payor?

A10: No, an electronic prescription will not be required. Section 281 (1) of the Public Health Law specifically references the use of electronic prescriptions for prescription drugs. A fiscal order may be required by third party payors for the purpose of payment. However, fiscal orders are not prescriptions and are not subject to the rules concerning electronic prescribing.

Q11: Can a Physician Assistant electronically prescribe controlled and non-controlled substances?

A11: Yes. All electronic prescriptions issued and signed by a Physician Assistant must contain the name of their supervising physician.

Q12: Is the supervising physician's name required on an electronic prescription issued by a physician assistant?

A12: Yes, the supervising physician's name is required on all prescriptions (controlled and noncontrolled substances) issued by a physician assistant, including electronic prescriptions, handwritten official prescriptions, and official prescriptions generated on an EMR system.

Q13: Can a physician assistant register for EPCS if their supervising physician does not?

A13: Yes. The supervising physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances.

Note: Both the supervising physician and physician assistant must maintain active registrations for the Official Prescription Program.

Q14: Can an unlicensed resident, intern or foreign physician electronically prescribe controlled and non-controlled substances?

A14: Yes. Please refer to 10 NYCRR 80.75 for further information.

Q15: Is a resident, intern or foreign physician's supervising physician/attending's name or signature required to be on an electronic prescription?

A15: BNE does not require the supervising physician/attending's name or signature to be on an electronic prescription, however third party payors or government programs may have additional requirements.

Q16: Is an attending physician that oversees residents, foreign physicians, and interns required to register for EPCS?

New York State Department of Health

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Electronic Prescribing of Controlled Substances

Frequently Asked Questions

A16: The attending physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances.

Q17: Are unlicensed medical residents required to register their EPCS software with BNE?

A17: No. The facility must maintain a current list of unlicensed residents with prescriptive privileges within the facility who have been authorized to access the facility's EPCS software. This information must be available to BNE upon request.

Q18: Does a practitioner still have to consult the Prescription Monitoring Program (PMP) Registry when e-prescribing?

A18: Yes. The practitioner must consult the PMP Registry prior to prescribing a controlled substance in Schedules II-IV regardless of how the prescription is issued.

Q19: Will it be permissible for a NY practitioner to fax a prescription for a 30 day supply of a controlled substance for a patient in a Hospice Program or a RHCF to a NY pharmacy once eprescribing becomes mandatory?

A19: No, unless the prescription is issued pursuant to one of the exceptions in the regulation, 10NYCRR Sec. 80.64. Faxed prescriptions are not considered electronic prescriptions.

Q20: I am not licensed or practicing in New York, but have a patient who uses a pharmacy in New York. Do I have to register my certified EPCS software application with BNE to send electronic prescriptions for controlled substances to pharmacies in the state of New York?

A20: Practitioners who are not practicing in New York State are not required to register their certified EPCS software application with BNE. They must follow their state's law and regulations.

Q21: Can I send an electronic prescription for a controlled substance to an out-of-state pharmacy?

A21: You may or may not be able to depending upon the laws of that state. The pharmacy must dispense the prescription following the laws of the state in which the prescription is being dispensed.

Q22: I don't have a DEA number, therefore, I don't prescribe controlled substances. Do I have to register the software application used to electronically prescribe non-controlled substances with BNE?

A22: There is no current requirement to register E-prescribing software applications that only transmit non-controlled substance prescriptions. However, all prescriptions must be issued electronically unless an exception applies.

Q23: Should I return all of my unused Official New York State Prescription forms to BNE?

A23: Not necessarily. Under limited circumstances, the use of an Official NYS Prescription form will still be allowed, including events of a power outage or technological failure. However, it is unlikely that practitioners and institutions will need to continue to keep a similar inventory as in the past. Please consider the amount of prescription paper you will need to keep on hand, safeguard any stored Official New York State Prescription forms and return unneeded or unwanted forms to the Bureau of Narcotic

New York State Department of Health

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Bureau of Narcotic Enforcement

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

Enforcement at 150 Broadway, Albany, NY 12204. The Bureau of Narcotic Enforcement will continue to supply Official New York State Prescription forms to practitioners and institutions.

Q24: I am a veterinarian and would like to electronically prescribe controlled substances. What should I do?

A24: Practitioners issuing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health requires practitioners licensed in New York State issuing electronic prescriptions for controlled substances to register their certified EPCS software application with BNE.

Q25: Does an electronic prescription for a controlled substance require a follow-up hard copy prescription?

A25: No.

Q26: Is it mandatory for pharmacies to receive electronic prescriptions for controlled substances?

A26: No. However, it will be mandatory for practitioners, with some exceptions, to issue electronic prescriptions for both controlled and non-controlled substances effective March 27, 2016.

Q27: What should I do if I am notified that the security of my certified EPCS software application is noncompliant with federal requirements?

A27: If your EPCS software application no longer meets federal security requirements, your software shall NOT be used to process electronic prescriptions for controlled substances until your software is in compliance with DEA requirements and you re-register the software application with BNE.

Q28: What should I do if my credentials used to sign electronic prescriptions have been lost, stolen or compromised?

A28: In addition to any federal requirements, practitioners must immediately notify BNE that his or her credentials have been lost, stolen or compromised. Please send an email to narcotic@health.state.ny.us with the subject of credentials lost, stolen or compromised or call BNE's toll free number (866-811-7957, Option 1).

Q29: What should I do if I suspect or am notified of a security breach with my certified EPCS software application?

A29: If there has been a security breach, you may not process electronic prescriptions for controlled substances. You must notify the DEA and BNE. After security has been restored, you must re-register the certified software application with BNE.

Q30: What is the difference between the third party audit or certification required by the DEA and the registration that BNE requires?

New York State Department of Health

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Bureau of Narcotic Enforcement

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

A30: Practitioners and pharmacies processing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health does not certify software applications. However, practitioners and pharmacies licensed in New York State processing electronic prescriptions for controlled substances are required to register their certified EPCS software application with BNE.

Q31: Why do I need to register my certified EPCS software application with the Bureau of Narcotic Enforcement (BNE)? My software vendor already notified BNE.

A31: Each individual practitioner and pharmacy, not the software vendor, is required by regulation to register their certified EPCS software application with BNE.

Q32: Can pharmacies receive electronic prescriptions for controlled substances from practitioners before it becomes mandated on March 27, 2016?

A32: Yes, EPCS became permissible in New York State on March 27, 2013. The pharmacy can receive electronic prescriptions for controlled substances provided that it has met the following requirements;

The pharmacy software application meets all of the federal security requirements included in the DEA's Interim Final Rule.

The pharmacy can submit controlled substance prescription data to BNE using ASAP version 4.2. The certified pharmacy software application is registered with BNE.

Q33: My pharmacy is NOT physically located in New York, however, it is registered with the New York State Board of Pharmacy. Are we required to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?

A33: Yes, non-resident pharmacies registered with the New York State Board of Pharmacy must register their certified pharmacy software application with BNE to receive electronic prescriptions for controlled substances.

Q34: My pharmacy is NOT located in New York. We are NOT registered with the New York State Board of Pharmacy. Do we have to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?

A34: No, pharmacies located outside of New York State that are NOT registered with the New York State Board of Pharmacy are not required to register their certified software applications with BNE.

Q35: Is the prescription valid for dispensing if the practitioner has not registered their certified EPCS application with BNE?

A35: Yes. The prescription is valid for dispensing if the practitioner has not registered their certified EPCS software application with BNE and the prescription meets all other federal and State requirements. Pharmacists are not expected to verify that a practitioner has registered their application with BNE.

New York State Department of Health

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Bureau of Narcotic Enforcement

Electronic Prescribing of Controlled Substances

Frequently Asked Questions

Q36: Can I accept an out-of-state electronic prescription for a controlled substance?

A36: A pharmacist may dispense a controlled substance medication pursuant to an out-of-state electronic prescription as defined in Section 80.78 Title 10 Part 80 Rules and Regulations on controlled substances. Electronic prescriptions may be created, signed and transmitted from another state, provided the practitioner complies with all requirements, state and federal, for issuing controlled substance prescriptions electronically. It is prudent on the part of the pharmacist to verify the authenticity of any controlled substance prescription presented to them.

Q37: May a pharmacist accept an Official New York State Prescription written prior to March 27, 2016?

A37: Yes. The prescription is written on an Official New York State Prescription form prior to the effective date of the statute.

Q38: May a pharmacist dispense an authorized refill from an Official New York State Prescription issued prior to March 27, 2016?

A38: Yes. The prescription, issued on an Official New York State Prescription form, with refills was written prior to the effective date of the statute.

Q39: Is a pharmacist who is presented with a prescription issued on Official New York State Prescription form after March 27, 2016 required to verify that the practitioner properly falls under one of the exceptions from the requirement to electronically prescribe?

A39: No. However, a corresponding liability for the proper prescribing and dispensing of controlled substances rests with the pharmacist who fills the prescription.

Q40: If a pharmacy does not dispense controlled substances, does their computer system have to be certified to meet the DEA security standards?

A40: No. Computer systems only need to be certified that they meet the DEA security standards if they will be used to dispense controlled substances.

Physician Assistant and Pharmacy EPCS Registration Form

Physician Assistant:

Q41: How do I fill out the registration form?

A41: Complete all fields on the form. Incomplete forms will not be accepted by BNE. Below is a summary of each field and the information to be entered.

a. Practitioner Name: Enter your first and last name in this field. Please attach a list of your Supervising Physician(s) with their corresponding NYS license number and DEA registration number.

New York State Department of Health

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Bureau of Narcotic Enforcement

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